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Transversalis Fascial Plane Nerve Block in Iliac Crest Bone Graft

Primary Purpose

Upper Limb Surgery, Iliac Crest Bone Harvest

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Active treatment

Placebo Arm

About this trial

This is an interventional treatment trial for Upper Limb Surgery focused on measuring supraclavicular nerve block, regional anesthesia, transversalis fascia plane block, ultrasound guided, opioid consumption, iliac crest bone harvest, hand surgery, wrist surgery, Upper limb surgery combined with iliac crest bone harvest.

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ASA physical status I-III
18-85 years of age, inclusive
Weight 50kg+
Scheduled for elective upper limb surgery, which can be solely performed under a brachial plexus block, and requiring an ICBG

Exclusion Criteria:

Contraindications to regional blockade (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
Pregnancy
History of alcohol or drug dependency/abuse
History of long term opioid intake or chronic pain disorder
History of significant psychiatric conditions that may affect patient assessment
Failure of upper extremity block
Previous iliac crest bone grafting
History of severe pelvic and hip conditions that could interfere with the long-term functional assessments of the study
Inability to understand the informed consent and demands of the study.

Sites / Locations

Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active treatment group

Placebo arm

Arm Description

Ultrasound-guided TFP block with 20ml 0.5% ropivacaine + 1:200 000 epinephrine

Ultrasound-guided TFP block with 20ml of 5% dextrose solution

Outcomes

Primary Outcome Measures

Opioid consumption

Opioid consumption in the first 24 hours following ICBG. This will be expressed in terms of milligrams doses of IV morphine. Where other opioids are used, the doses will be converted to the equivalent IV morphine dose using standard opioid dosage conversion tables.

Secondary Outcome Measures

Opioid consumption

Opioid consumption (expressed as milligram doses of IV morphine) in the following phases Intraoperative phase (from start of surgery to end of surgery) Postoperative care unit stay (from admission to discharge) First 48 hours following ICBG

Pain measures

Pain scores at the ICBG site, measured using a visual analogue scale (VAS) (scale 0-10) and starting in recovery, then every 4 hrs for the next 48 hrs. Pain at the primary surgical site (VAS 0-10) Duration of block, defined as the time from completion of block performance to the time of onset of increased pain at the ICBG harvest site (as perceived by the patient)

Time of block performance

Time required to perform the TFP block (defined as the time between placement of the ultrasound probe on the patient, and withdrawal of the block needle)

Complications

TFP block complications and adverse events (e.g. vascular puncture, intravascular local anesthetic injection and local hematoma)

Full Information

NCT ID

NCT01133730

First Posted

May 27, 2010

Last Updated

December 13, 2017

Sponsor

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT01133730

Brief Title

Transversalis Fascial Plane Nerve Block in Iliac Crest Bone Graft

Official Title

The Analgesic Efficacy of the Transversalis Fascia Plane Block in Iliac Crest Bone Graft Harvesting

Study Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Completed

Study Start Date

August 2010 (Actual)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Hand or wrist surgery often requires the use of bony material in order to accomplish any associated reconstructive aspects required for the surgery. The iliac crest is often used as the source of bone for such surgery and harvesting from this site is performed simultaneously with the hand/wrist surgery. In terms of anesthesia, patients typically receive a supraclavicular nerve block for the hand/wrist surgery, and a general anesthestic for the bone graft, though spinal block may also be performed. This study will look at the use of a transversalis fascia plane (TFP) nerve block (ie, to numb the nerves going to the iliac crest) in combination with a general anesthetic to see if post-operative pain and opioid consumption is reduced using the TFP block.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Upper Limb Surgery, Iliac Crest Bone Harvest

Keywords

supraclavicular nerve block, regional anesthesia, transversalis fascia plane block, ultrasound guided, opioid consumption, iliac crest bone harvest, hand surgery, wrist surgery, Upper limb surgery combined with iliac crest bone harvest.

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active treatment group

Arm Type

Experimental

Arm Description

Ultrasound-guided TFP block with 20ml 0.5% ropivacaine + 1:200 000 epinephrine

Arm Title

Placebo arm

Arm Type

Placebo Comparator

Arm Description

Ultrasound-guided TFP block with 20ml of 5% dextrose solution

Intervention Type

Drug

Intervention Name(s)

Active treatment

Intervention Description

US-guided TFP block with 20ml 0.5% ropivacaine + 1:200 000 epinephrine

Intervention Type

Drug

Intervention Name(s)

Placebo Arm

Intervention Description

US-guided TFP block with 20ml of 5% dextrose solution

Primary Outcome Measure Information:

Title

Opioid consumption

Description

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Opioid consumption

Description

Time Frame

7 days

Title

Pain measures

Description

Time Frame

48 hours

Title

Time of block performance

Description

Time required to perform the TFP block (defined as the time between placement of the ultrasound probe on the patient, and withdrawal of the block needle)

Time Frame

6 hours

Title

Complications

Description

TFP block complications and adverse events (e.g. vascular puncture, intravascular local anesthetic injection and local hematoma)

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA physical status I-III 18-85 years of age, inclusive Weight 50kg+ Scheduled for elective upper limb surgery, which can be solely performed under a brachial plexus block, and requiring an ICBG Exclusion Criteria: Contraindications to regional blockade (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area) Pregnancy History of alcohol or drug dependency/abuse History of long term opioid intake or chronic pain disorder History of significant psychiatric conditions that may affect patient assessment Failure of upper extremity block Previous iliac crest bone grafting History of severe pelvic and hip conditions that could interfere with the long-term functional assessments of the study Inability to understand the informed consent and demands of the study.

Facility Information:

Facility Name

Toronto Western Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

12. IPD Sharing Statement

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Transversalis Fascial Plane Nerve Block in Iliac Crest Bone Graft

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